JOHANNESBURG, Tuesday 20th January: The Treatment Action
Campaign (TAC), Doctors Without Borders (MSF) and SECTION27 applaud
India’s decision to reject a patent application on sofosbuvir, an
important new treatment for Hepatitis C. Last Wednesday’s decision paves
the way for increased access to more affordable sofosbuvir in India and
other countries who choose to implement legal flexibilities available
under international law to increase access to the drug. However,
existing patents on sofosbuvir in South Africa could block access to the
cheaper generic versions that will become available due to the ruling.
The government should therefore urgently finalise the national
intellectual property policy to allow South Africa to better protect
access to medicines.

Rejection of the patent in India will allow generic manufacturers that
have not already signed restrictive licensing agreements with Gilead to
produce sofosbuvir at much lower prices than currently available.
Research conducted by Dr Andrew Hill at the University of Liverpool, for
example, suggests that sofosbuvir can be profitably produced for as
little as $102 (R1,182) per 12 week course.

However, patent protection in South Africa prevents open competition,
and could block generic versions of sofosbuvir and other new HCV drugs
from reaching the domestic market. The same sofosbuvir patent rejected
in India was granted in South Africa, and will only expire in 2025.
South Africa has also granted multiple ‘secondary’ patents on
sofosbuvir, with the latest patent only expiring in 2034. If reforms
proposed in South Africa’s draft intellectual property policy are
implemented, the number of such secondary patents granted will be
dramatically reduced.